France is a Significant Market for Intravitreal Steroid Use
ATLANTA, GA / ACCESSWIRE / March 6, 2019 / Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that its subsidiary, Alimera Sciences Limited, received a positive resolution for the pricing and reimbursement approval for ILUVIEN® from Comité Economique des Produits de Santé (CEPS). This means that in France, ILUVIEN will be fully reimbursed for use in line with the European label indication. This approval was sought and secured by Alimera's distributor partner in France, Horus Pharma S.A.S. (Horus). ILUVIEN is a sustained release intravitreal implant indicated in the EU to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
''France is a very strong intraocular steroid market and we believe the availability of an innovative product to uniquely treat the disease consistently every day to reduce the recurrence of edema will be welcomed by retinal specialists and patients.'' said Rick Eiswirth, Alimera's President and CEO. ''The knowledge and expertise of Horus regarding pricing and reimbursement has now made ILUVIEN and its CONTINUOUS MICRODOSINGTM Delivery available to patients in France and completes reimbursement in the five biggest European countries.''
''In DME, there is a great place for corticosteroid therapy and France is the European country that uses the most intravitreal steroid treatment for DME. Despite this higher usage, some patients respond poorly or need more continuous treatment,'' said Professor Laurent Kodjikian, President of the French Society of Ophthalmology. ''Thus, ILUVIEN is greatly anticipated in France and will respond to a real market demand. Its efficacy profile is attractive, and its tolerance considered as good thanks to quarterly monitoring.''
ILUVIEN will be distributed throughout France by Horus. Under the terms of the agreement, Horus is handling all promotion, marketing and commercial activities for ILUVIEN, and was responsible for the successful pursuit of this approval.
''We are particularly delighted with the acceptance by the CEPS (French Economic Committee) for the therapeutic care of ILUVIEN in France. This decision, expected by many ophthalmologists and patients, will offer an alternative to patients with diabetic macular edema who have shown an insufficient response to previous treatment'', stated Dr. Claude Claret, CEO and Co-founder of Horus. ''We are genuinely pleased that the collaboration agreement with Alimera Sciences is rapidly materializing through the distribution and launching of ILUVIEN in France. It is with great pride that Horus will contribute to improving the supply of care in this growing and rapidly evolving disease. This launch will allow Horus to expand its therapeutic range and become a leading generalist ophthalmology company.''
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the EU to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant with its continuous microdosing delivery is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, enabling the physician to treat this persistent disease consistently every day.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
About Horus Pharma S.A.S.
Founded in 2003, Horus Pharma is an independent French laboratory specialized in ophthalmology. Horus is a European and independent ophthalmology laboratory and has been recognized to date as one of the main innovative European actors in corneal reconstruction treatments, particularly in the areas of dry eye, scarring and keratoconus. Focused on patient safety, Horus has developed recognized expertise in the development of preservative-free formulations and product delivery systems. For further details, please visit www.horus-pharma.com.
Forward Looking Statements
This press release contains ''forward-looking statements,'' within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's expectations regarding the receipt of revenue from the sale of ILUVIEN by its distributor in France. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the sufficiency of insurance reimbursement by the French authorities, Horus's ability to timely launch ILUVIEN in 2019 in France in a meaningful way and to provide adequate promotion, marketing and commercial support for ILUVIEN, and the degree to which physicians and hospitals in France accept ILUVIEN for administration to their DME patients, as well as other factors, including those discussed in the ''Risk Factors'' and ''Management's Discussion and Analysis of Financial Condition and Results of Operations'' sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2018and Quarterly Report on Form 10-Q for the quarter ended December 31, 2018, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. In addition to the risks described above, and in Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera's results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE: Alimera Sciences, Inc.